Drugs / Tofacitinib
Tofacitinib
also known as
CP-690,550 · Xeljanz · tasocitinib · Tofacitinib Citrate · TOF · CKD-374 · CP-6890,550 · CP-690 · +14 more
Small molecule targets JAK1, JAK3, STAT3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 19 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ankylosing spondylitis 1 milestone | |||||
| Filed | US (FDA) | — | ankylosing spondylitis | 2020-11-06 | “The FDA has accepted Pfizer’s application for the AS indication and the Prescription Drug User Fee Act (PDUFA) goal date is in Q2 2021.” pfizer.com ↗ |
| Filed rheumatoid arthritis 1 milestone | |||||
| Filed | EU (EMA) | XELJANZ | rheumatoid arthritis | 2016-03-23 | “the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for XELJANZ” pfizer.com ↗ |
| Filed ulcerative colitis 2 milestones | |||||
| Filed | EU (EMA) | XELJANZ | ulcerative colitis | — | “Applications for tofacitinib for the treatment of moderately to severely active UC are currently under review by the U.S. FDA and the European Medicines Agency” pfizer.com ↗ |
| Filed | US (FDA) | XELJANZ | ulcerative colitis | — | “Pfizer’s supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), which is currently under review by the FDA” pfizer.com ↗ |
| Rejected psoriasis 1 milestone | |||||
| Rejected (CRL) | US (FDA) | XELJANZ | psoriasis | 2015-10-14 | “received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ” pfizer.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (7) | US (FDA) | XELJANZ | — | 2013-11-18 – 2026-03-06 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | XELJANZ XR | — | 2017-08-22 – 2021-12-14 | fda.gov ↗ |
| Approved | EU (EMA) | Xeljanz | — | 2017-03-22 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Xeljanz | — | 2013-07-25 | europa.eu ↗ |
| Approved | US (FDA) | XELJANZ | — | 2012-11-06 | fda.gov ↗ |
Trials 210 · started per year
today
US approved 2012
EU approved 2017
1
3
4
6
8
8
17
9
9
7
10
3
5
7
3
13
18
12
15
13
13
12
14
20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 07 trials | ||||||
| Phase 0 | NCT07055529 | Jun → Dec 2026 expected | generalized vitiligo | Hayat Abad Medical Complex, Peshawar | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06689982 | Dec 2024 → Dec 2025 overdue | amyotrophic lateral sclerosis | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06119490 | Jul 2023 → Jul 2026 overdue | toxic epidermal necrolysis | Peng Zhang | Recruiting | No outcome recorded |
| Phase 0 | NCT06157905 | Aug 2022 → Feb 2023 | alopecia areata | Services Institute of Medical Sciences, Pakistan | Completed | No outcome recorded |
| Phase 0 | NCT05293119 | May 2022 → May 2023 | vitiligo | Pi Research Consultancy Center, Bangladesh | Unknown | No outcome recorded |
| Phase 0 | NCT04431895 | Jun 2020 → Mar 2024 | generalized myasthenia gravis | Huashan Hospital | Completed | No outcome recorded |
| Phase 0 | NCT03159936 | Apr 2017 → May 2020 | discoid lupus erythematosus, systemic lupus erythematosus | Tufts Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 144 trials · 3 met primary · 1 missed | ||||||
| Phase 1 | NCT07843693 | Aug → Dec 2026 expected | — | AbbVie | Recruiting | No outcome recorded |
| Phase 1 | NCT06275464 | Jan → Apr 2024 | — | Biora Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05048238 | Sep 2022 → Feb 2024 | cutaneous lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT04985955 | Jul → Sep 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04468425 | Oct → Dec 2020 | — | TWi Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04338711 | Jun → Sep 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04114461 | Nov → Dec 2019 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04111614 | Oct → Dec 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04034238 | Aug 2019 → Dec 2020 | extrahepatic bile duct carcinoma, malignant epithelioid mesothelioma, pancreatic adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT04278391 | Jul → Aug 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 1 | NCT03793439 | May 2019 → Jun 2020 | pulmonary sarcoidosis | Oregon Health and Science University | Completed | Met primary |
| Phase 1 | NCT03910543 | Apr 2019 → Jun 2021 | granuloma annulare, skin sarcoidosis | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT03858725 | Feb → Apr 2019 | rheumatoid arthritis | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT04403776 | Dec 2018 → Feb 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03112148 | Sep → Nov 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03002649 | Jan 2017 → Sep 2020 | dermatomyositis | Johns Hopkins University | Completed | Met primary |
| Phase 1 | NCT02487433 | Jun → Jul 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02193815 | Sep 2014 → Feb 2015 | psoriasis | Pfizer | Completed | Missed primary |
| Phase 1 | NCT02084875 | Apr → May 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01513902 | Mar 2013 → Dec 2015 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01731327 | Nov → Dec 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01741493 | Nov 2012 → Dec 2013 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01499004 | Nov → Dec 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01405118 | Jun → Jul 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01262118 | May 2011 → Jan 2012 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01277991 | Feb → Mar 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01101919 | Oct 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01202240 | Sep 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01204112 | Sep → Oct 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01184001 | Sep 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01184092 | Aug → Sep 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01185184 | Aug 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01143805 | Jul → Aug 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01137708 | Jun → Jul 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01023100 | Mar 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00969813 | Nov 2009 → Jan 2010 | liver disorder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00902460 | Jun → Jul 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00860496 | Jun → Aug 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01743677 | Oct 2007 → Feb 2008 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01745055 | Apr 2005 → Jun 2006 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01740362 | Oct 2003 → Mar 2004 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01710033 | Sep 2003 → Apr 2005 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01710020 | Feb → Jun 2003 | end stage renal failure | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01736696 | Nov 2002 → Apr 2004 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 1/26 trials · 1 missed | ||||||
| Phase 1/2 | NCT05487963 | Nov 2022 → Jun 2023 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05104723 | Aug 2022 → May 2026 | chronic granulomatous disease, inflammatory bowel disease, lung disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT04496960 | May 2021 → Jan 2025 overdue | Sjogren syndrome | National Institute of Dental and Craniofacial Research (NIDCR) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04141904 | Feb 2020 → May 2022 | major depressive disorder | University of Oxford | Terminated | No outcome recorded |
| Phase 1/2 | NCT03288324 | Aug 2017 → Nov 2022 | cutaneous lupus erythematosus, systemic lupus erythematosus | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1/2 | NCT00784719 | Nov 2008 → Oct 2009 | dry eye syndrome | Pfizer | Completed | Missed primary |
| Phase 266 trials · 7 met primary · 4 missed | ||||||
| Phase 2 | NCT07313072 | Sep 2026 → Apr 2027 expected | psoriasis | Hexsel Dermatology Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07522801 | Sep 2026 → Dec 2029 expected | — | Philippe ROUSSELOT | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07598643 | May 2026 → Aug 2030 expected | Down syndrome | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT07547930 | Apr 2026 → Dec 2027 expected | disease of orbital part of eye adnexa | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07530224 | Mar → Dec 2026 expected | — | Shixiu Wu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07297069 | Jan 2026 → May 2027 expected | ulcerative colitis | Asian Institute of Gastroenterology, India | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281456 | Dec 2025 → Dec 2030 expected | Sjogren syndrome | National Institute of Dental and Craniofacial Research (NIDCR) | Recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06923228 | Apr → Jul 2025 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06698822 | Mar 2025 → Jun 2027 expected | primary cutaneous T-cell lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06810050 | Dec 2024 → Aug 2025 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06393972 | Jul 2024 → Nov 2025 overdue | toxic myocarditis | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06044844 | Nov 2023 → May 2024 | — | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT05662228 | Jun 2023 → May 2026 | Down syndrome | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT05845723 | Jun 2023 → Jun 2026 overdue | Behcet disease | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05246293 | Aug 2022 → Mar 2024 | interstitial lung disease, rheumatoid arthritis | National Institute of Respiratory Diseases, Mexico | Unknown | No outcome recorded |
| Phase 2 | NCT05165771 | Jul 2022 → Feb 2023 | rheumatoid arthritis | Gilead Sciences | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05400889 | Jun 2022 → Mar 2023 | idiopathic inflammatory myopathy | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05348213 | May 2022 → Jun 2025 overdue | diffuse large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04768504 | Mar 2022 → Jan 2024 | — | Khashayar Esfahani | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05087589 | Nov 2021 → Jan 2023 | Sjogren syndrome | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04925973 | Jun 2021 → Dec 2023 overdue | ulcerative colitis | McMaster University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04580277 | Jan 2021 → Dec 2022 | pouchitis | Cedars-Sinai Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04799262 | Jan 2021 → Mar 2022 | polymyalgia rheumatica | RenJi Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04246372 | Oct 2020 → Oct 2024 | Down syndrome, alopecia areata, atopic eczema, hidradenitis suppurativa +2 | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT04415151 | Oct 2020 → Feb 2021 | pneumonia | Yale University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04413617 | Jul 2020 → Feb 2022 | rheumatoid arthritis | Pfizer | Completed | Mixed |
| Phase 2 | NCT04412252 | Jul → Sep 2020 | COVID-19 | Pfizer | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04390061 | Jun → Sep 2020 | COVID-19, interstitial lung disease | Marche Polytechnic University | Unknown | No outcome recorded |
| Phase 2 | NCT04750317 | May → Aug 2020 | COVID-19 | I.M. Sechenov First Moscow State Medical University | Completed | No outcome recorded |
| Phase 2 | NCT04332042 | Apr → Jun 2020 | interstitial lung disease | Marche Polytechnic University | Unknown | No outcome recorded |
| Phase 2 | NCT03681275 | Sep 2019 → Aug 2026 overdue | diaphragm disorder | Stanford University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03580343 | Apr → Dec 2019 | scleritis, uveitis | Washington University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT03598959 | Jan → Dec 2019 | extranodal nasal NK/T cell lymphoma | Sichuan University | Unknown | No outcome recorded |
| Phase 2 | NCT02812342 | Sep 2016 → Jul 2018 | alopecia areata, alopecia totalis, alopecia universalis | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT02299297 | Jan 2015 → Dec 2017 | alopecia areata | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT02197455 | Jul 2014 → Jul 2015 | alopecia areata, alopecia totalis, alopecia universalis | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT02147587 | Jun 2014 → Jun 2015 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02001181 | Dec 2013 → Sep 2014 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 2 | NCT01831466 | May 2013 → Sep 2014 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01786668 | Apr 2013 → Mar 2015 | ankylosing spondylitis | Pfizer | Completed | Mixed |
| Phase 2 | NCT01710046 | Mar → Nov 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01470599 | Apr 2012 → Jul 2016 | Crohn disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01393899 | Mar 2012 → Jul 2015 | Crohn disease | Pfizer | Completed | Missed primary |
| Phase 2 | NCT01393626 | Oct 2011 → Feb 2015 | Crohn disease | Pfizer | Completed | Missed primary |
| Phase 2 | NCT01359150 | Sep 2011 → Feb 2012 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01246583 | Feb → Nov 2011 | psoriasis | Pfizer | Completed | Mixed |
| Phase 2 | NCT01226680 | Dec 2010 → Oct 2012 | dry eye syndrome | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT01164579 | Oct 2010 → Nov 2013 | rheumatoid arthritis | Pfizer | Completed | Mixed |
| Phase 2 | NCT01135511 | Jul 2010 → Apr 2011 | dry eye syndrome | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01059864 | Feb → Nov 2010 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 2 | NCT00976599 | Nov 2009 → Jul 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00687193 | Mar 2009 → Jul 2010 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 2 | NCT00787202 | Dec 2008 → Sep 2010 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00678561 | Oct 2008 → Jul 2009 | psoriasis | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00658359 | Aug 2008 → Mar 2015 | — | Pfizer | Completed | Mixed |
| Phase 2 | NCT00678210 | Jul 2008 → Aug 2009 | psoriasis | Pfizer | Completed | Met primary |
| Phase 2 | NCT00615199 | Jan 2008 → Oct 2009 | Crohn disease | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00603512 | Jan → Sep 2008 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00550446 | Sep 2007 → Jan 2009 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 2 | NCT00556257 | Aug 2007 → ? | — | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT00483756 | Aug 2007 → Feb 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00413660 | Jan 2007 → Aug 2008 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 2 | NCT00263328 | Dec 2005 → Jan 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00106639 | May 2005 → Jul 2006 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00147498 | Jan 2005 → Jun 2006 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06011343 | Oct 2023 → Oct 2024 | cutaneous leishmaniasis | Hospital Universitário Professor Edgard Santos | Unknown | No outcome recorded |
| Phase 2/3 | NCT03738956 | Sep 2017 → Dec 2018 | spondyloarthropathy | Globe Pharmaceuticals Limited | Unknown | No outcome recorded |
| Phase 2/3 | NCT01500551 | Mar 2013 → Feb 2025 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 335 trials · 14 met primary · 1 missed | ||||||
| Phase 3 | NCT07530367 | Apr 2026 → Apr 2028 expected | palmoplantar pustulosis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04871191 | Jun 2025 → Oct 2028 expected | granulomatosis with polyangiitis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT07008846 | May 2025 → Sep 2026 overdue | rheumatoid arthritis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06172361 | Jan 2024 → May 2026 | polymyalgia rheumatica | Zhejiang University | Completed | No outcome recorded |
| Phase 3 | NCT06278402 | Jul 2023 → Jan 2024 | alopecia areata, alopecia totalis, alopecia universalis | Jinnah Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT05749666 | Jan 2023 → Jul 2025 | Takayasu arteritis | Chinese SLE Treatment And Research Group | Unknown | No outcome recorded |
| Phase 3 | NCT05326464 | Oct 2022 → Feb 2025 | glioblastoma | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT04624230 | Aug 2021 → Apr 2027 expected | ulcerative colitis | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT04469114 | Sep 2020 → Jan 2021 | COVID-19 | Hospital Israelita Albert Einstein | Completed | Met primary |
| Phase 3 | NCT03502616 | Jun 2018 → Dec 2019 | ankylosing spondylitis | Pfizer | Completed | Met primary |
| Phase 3 | NCT03000439 | May 2018 → Mar 2024 | systemic-onset juvenile idiopathic arthritis | Pfizer | Completed | Missed primary |
| Phase 3 | NCT03736161 | Sep 2017 → Sep 2019 | psoriatic arthritis | Globe Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 3 | NCT02592434 | Jun 2016 → May 2019 | juvenile idiopathic arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT02566967 | May 2015 → Dec 2017 | rheumatoid arthritis | Norman B. Gaylis, MD | Completed | No outcome recorded |
| Phase 3 | NCT01976364 | Feb 2014 → May 2019 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01877668 | Jan 2014 → Dec 2015 | psoriatic arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01815424 | Dec 2013 → Jul 2015 | psoriasis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01470612 | Oct 2012 → Aug 2020 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01458574 | Jul 2012 → May 2016 | ulcerative colitis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01458951 | Jun 2012 → May 2015 | ulcerative colitis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01465763 | Apr 2012 → May 2015 | ulcerative colitis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01519089 | Mar 2012 → Jan 2014 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01276639 | Mar 2011 → Apr 2013 | psoriasis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01309737 | Mar 2011 → Apr 2013 | psoriasis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01241591 | Nov 2010 → Jan 2013 | psoriasis | Pfizer | Completed | Mixed |
| Phase 3 | NCT01186744 | Sep 2010 → Jan 2013 | psoriasis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01163253 | Sep 2010 → Jun 2016 | psoriasis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT01039688 | Jan 2010 → Mar 2013 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00856544 | May 2009 → Jan 2011 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00853385 | May 2009 → Mar 2011 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00814307 | Feb 2009 → Jun 2010 | rheumatoid arthritis | Pfizer | Completed | Mixed |
| Phase 3 | NCT00661661 | Apr 2008 → Dec 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00413699 | Feb 2007 → Nov 2016 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 436 trials · 2 met primary · 3 missed | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07636057 | Jul 2026 → Mar 2027 expected | rheumatoid arthritis | Sheikh Zayed Federal Postgraduate Medical Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07406204 | Feb → Aug 2026 overdue | alopecia areata, alopecia totalis, alopecia universalis | Hayat Abad Medical Complex, Peshawar | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07554820 | Dec 2025 → Aug 2026 overdue | rheumatoid arthritis | Shaikh Zayed Hospital, Lahore | Recruiting | No outcome recorded |
| Phase 4 | NCT07131813 | Oct 2025 → Jan 2027 expected | lichen planus, oral | All India Institute of Medical Sciences, Bhubaneswar | Recruiting | No outcome recorded |
| Phase 4 | NCT07160231 | Sep 2025 → May 2028 expected | psoriatic arthritis, spondyloarthropathy | Sint Maartenskliniek | Recruiting | No outcome recorded |
| Phase 4 | NCT06945666 | Aug 2025 → Jan 2027 expected | rheumatoid arthritis | Jie Chang | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06998875 | Mar → Oct 2025 overdue | primary cutaneous amyloidosis | Army Medical University, China | Recruiting | No outcome recorded |
| Phase 4 | NCT06465732 | Jan → Nov 2025 overdue | atopic eczema | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07472166 | Dec 2024 → Aug 2025 | systemic sclerosis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT06660329 | Oct 2024 → Oct 2027 expected | Blau syndrome | Peking Union Medical College Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06498089 | Jun 2024 → Jun 2026 overdue | Takayasu arteritis | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06095128 | Jun 2024 → Jul 2027 expected | ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT06438679 | Mar → Sep 2024 overdue | dermatomyositis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06112665 | Nov 2023 → Mar 2025 overdue | spondyloarthropathy | Charite University, Berlin, Germany | Recruiting | No outcome recorded |
| Phase 4 | NCT05606107 | May 2022 → Jun 2024 | rheumatoid arthritis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT05313620 | Apr 2022 → Jun 2026 | ulcerative colitis, venous thromboembolism | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT06310057 | Jan 2022 → Mar 2024 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT05102448 | Nov 2021 → Dec 2025 overdue | Takayasu arteritis | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04944524 | Jul 2021 → Jul 2024 | granulomatosis with polyangiitis | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06146972 | Jun 2021 → Mar 2024 | rheumatoid arthritis | Yanfeng Hou | Unknown | No outcome recorded |
| Phase 4 | NCT04927000 | May 2021 → Aug 2022 | rheumatoid arthritis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04311567 | Nov 2020 → Nov 2023 | interstitial lung disease, rheumatoid arthritis | Vastra Gotaland Region | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04966884 | Apr 2020 → Dec 2021 | anti-MDA5 dermatomyositis | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT04928066 | Mar 2020 → Jun 2023 | rheumatoid arthritis | Qilu Hospital of Shandong University | Completed | No outcome recorded |
| Phase 4 | NCT04299971 | Mar 2020 → Dec 2022 | Takayasu arteritis | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04464642 | Jul 2019 → Aug 2020 | rheumatoid arthritis | Dr. Mohammad Mamun Khan | Unknown | Missed primary |
| Phase 4 | NCT03800979 | Jan 2019 → Jan 2021 | alopecia areata | Institute of Dermatology, Thailand | Completed | No outcome recorded |
| Phase 4 | NCT03281304 | Nov 2017 → Feb 2020 | ulcerative colitis | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02831855 | Sep 2016 → Nov 2018 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02321930 | Feb 2016 → Sep 2017 | rheumatoid arthritis | University of California, Los Angeles | Completed | Met primary |
| Phase 4 | NCT02187055 | Aug 2014 → Dec 2016 | rheumatoid arthritis | Pfizer | Completed | Missed primary |
| Phase 4 | NCT02157012 | May 2014 → Apr 2022 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 4 | NCT02092467 | Mar 2014 → Jul 2020 | rheumatoid arthritis | Pfizer | Completed | Missed primary |
| Phase not applicable13 trials | ||||||
| — | NCT07406932 | May 2026 → Jul 2027 expected | antisynthetase syndrome, interstitial lung disease | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| — | NCT07343635 | Feb 2026 → Jul 2027 expected | rosacea | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | No outcome recorded |
| — | NCT06707246 | Dec 2024 → Oct 2026 expected | hidradenitis suppurativa | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT06301373 | Sep 2024 → Dec 2029 expected | rheumatoid arthritis | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT06201715 | May 2024 → Jun 2025 | prurigo nodularis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT06202560 | Nov 2023 → Jul 2024 | frontal fibrosing alopecia, lichen planopilaris | Institute of Dermatology, Thailand | Completed | No outcome recorded |
| — | NCT05112263 | Jul 2023 → Dec 2025 | ulcerative colitis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| — | NCT07827469 | Apr 2023 → Jun 2026 | immunoglobulin G4-related sclerosing disease | Peking University People's Hospital | Completed | No outcome recorded |
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| — | NCT06474078 | Aug 2022 → Jun 2025 | Stevens-Johnson syndrome | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| — | NCT04378621 | Oct 2020 → Sep 2025 | depressive disorder, rheumatoid arthritis, subjective cognitive decline | Vastra Gotaland Region | Unknown | No outcome recorded |
| — | NCT04973033 | Dec 2019 → Jan 2021 | anti-neutrophil cytoplasmic antibody-associated vasculitis, substance abuse | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| — | NCT02312882 | Dec 2014 → Aug 2015 | alopecia areata, alopecia totalis, alopecia universalis | Stanford University | Completed | No outcome recorded |
| Comparator or background therapy35 trials | ||||||
| Phase 0 | NCT07261306 Comparator | Aug → Dec 2025 overdue | psoriasis | Lahore General Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT07044141 Comparator | Mar → Sep 2025 overdue | vitiligo | Lahore General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04552197 Comparator | Sep → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02535689 Comparator | Aug 2015 → Apr 2018 | systemic lupus erythematosus | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 1 | NCT01484561 Comparator | Apr 2012 → Jan 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT03274076 Comparator | Sep 2017 → Apr 2019 | diffuse cutaneous systemic sclerosis, diffuse scleroderma | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT07406035 Comparator | Jul 2026 → Aug 2027 expected | psoriatic arthritis | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06176508 Comparator | Feb 2024 → Apr 2026 overdue | psoriatic arthritis | Hansoh BioMedical R&D Company | Recruiting | No outcome recorded |
| Phase 2 | NCT06114407 Comparator | Oct 2023 → Jun 2024 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT05814939 Comparator | Apr 2023 → May 2024 | ankylosing spondylitis | Jiangsu vcare pharmaceutical technology co., LTD | Completed | No outcome recorded |
| Phase 2 | NCT05133297 Comparator | Feb → Dec 2022 | rheumatoid arthritis | Hangzhou Highlightll Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04062695 Comparator | Aug 2020 → Dec 2023 | arthritis, sacroiliac, psoriatic arthritis, spondylitis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT03755466 Comparator | Nov 2018 → Nov 2023 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 2 | NCT02996500 Comparator | Nov 2016 → Aug 2018 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT06654882 Comparator | Jan 2026 → May 2029 expected | polyarticular juvenile idiopathic arthritis | Duke University | Recruiting | No outcome recorded |
| Phase 3 | NCT06020144 Comparator | Nov 2023 → Jan 2026 | rheumatoid arthritis | Hangzhou Highlightll Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04505410 Comparator | Sep 2020 → Dec 2023 | ulcerative colitis | University of Miami | Completed | No outcome recorded |
| Phase 3 | NCT03970837 Comparator | Jun 2019 → Oct 2021 | rheumatoid arthritis | GlaxoSmithKline | Terminated | Met primary |
| Phase 3 | NCT03980483 Comparator | May 2019 → Sep 2021 | rheumatoid arthritis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03486457 Comparator | Aug 2018 → Apr 2021 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02281552 Comparator | Nov 2014 → Mar 2017 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01882439 Comparator | Aug 2013 → Apr 2016 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00960440 Comparator | Oct 2009 → Mar 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00847613 Comparator | Mar 2009 → Apr 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 4 | NCT06687551 Comparator | Jan 2025 → Apr 2029 expected | rheumatoid arthritis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06625450 Comparator | Oct 2024 → Dec 2025 overdue | ulcerative colitis | Post Graduate Institute of Medical Education and Research, Chandigarh | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05803135 Comparator | Mar 2023 → Jan 2025 | rheumatoid arthritis | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05151848 Comparator | Jan 2022 → Jan 2026 | Takayasu arteritis | Chinese SLE Treatment And Research Group | Unknown | No outcome recorded |
| Phase 4 | NCT03976245 Comparator | Mar 2020 → Mar 2025 overdue | rheumatoid arthritis | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Recruiting | No outcome recorded |
| Phase 4 | NCT04485325 Comparator | Nov 2019 → Mar 2024 | rheumatoid arthritis | Dr. Frank Behrens | Completed | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03504072 Comparator | Jan 2018 → Jun 2019 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| — | NCT07581418 Comparator | Jun → Dec 2026 expected | psoriasis | Pak Emirates Military Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2024-07-02 | Biora Therapeutics, Inc. | Results Biora Therapeutics has positive oral drug delivery device data for treating ulcerative colitis bioratherapeutics.com ↗
Biora Therapeutics shared positive topline results from a trial of its orally administered drug-device combination for treating ulcerative colitis (UC). |
| 2023-03-21 | Zydus Lifesciences Limited | Regulatory Zydus receives final and tentative Approval from the USFDA for Tofacitinib Tablets, 5 mg and 10 mg, respectively zyduslife.com ↗
Zydus Pharmaceuticals (USA) Inc. has received final approval for Tofacitinib Tablets, 5 mg and tentative approval for Tofacitinib Tablets, 10 mg (USRLD: Xeljanz® Tablets) from the United States Food and Drug Administration (USFDA). |
| 2021-12-14 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Ankylosing Spondylitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ ® / XELJANZ ® XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. |
| 2021-11-18 | Pfizer | Regulatory Pfizer’s XELJANZ® (tofacitinib) Receives Marketing Authorization in the European Union for the Treatment of Active Ankylosing Spondylitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission has approved XELJANZ ® (tofacitinib) 5 mg twice daily for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. |
| 2021-10-15 | Pfizer | Regulatory Pfizer’s Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis pfizer.com ↗
The CHMP also adopted a positive opinion recommending an extension to the existing indications for XELJANZ® (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. |
| 2021-08-23 | Zydus Lifesciences Limited | Regulatory Zydus Cadila gets 180-day exclusivity for Tofacitinib extendedrelease 22 mg tablets, announces final approval from USFDA zyduslife.com ↗ |
| 2021-08-20 | Pfizer | Regulatory XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). |
| 2021-07-21 | Pfizer | Regulatory Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings pfizer.com ↗
The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions. |
| 2021-06-16 | Pfizer | Results Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia pfizer.com ↗
The trial demonstrated a lower cumulative incidence of death or respiratory failure through day 28 – the primary outcome of the study – with tofacitinib (18.1%) compared to placebo (29.0%) (risk ratio 0.63; 95% confidence interval [CI], 0.41 to 0.97; p=0.04). |
| 2021-04-07 | Pfizer | Regulatory Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis pfizer.com ↗ |
| 2021-01-27 | Pfizer | Results Pfizer Shares Co-Primary Endpoint Results from Post-Marketing Required Safety Study of XELJANZ® (tofacitinib) in Subjects with Rheumatoid Arthritis (RA) pfizer.com ↗
Results showed that for these co-primary endpoints, the prespecified non-inferiority criteria were not met for the primary comparison of the combined tofacitinib doses to TNFi. |
| 2020-11-06 | Pfizer | Results Pfizer Announces Positive Phase 3 Study Results for XELJANZ ® (tofacitinib) in Ankylosing Spondylitis (AS) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today positive results from a Phase 3 investigational study evaluating the safety and efficacy of tofacitinib in adults with active ankylosing spondylitis (AS). |
| 2020-10-19 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Tofacitinib Extended-Release Tablets zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: Xeljanz XR® Tablets). |
| 2020-09-28 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). |
| 2019-12-12 | Pfizer | Regulatory FDA Approves XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers. |
| 2019-11-12 | Pfizer | Results Pfizer Announces Results of Phase 3 Study for XELJANZ® (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting pfizer.com ↗
The trial met its primary endpoint showing that in patients with polyarticular JIA, the occurrence of disease flare in patients treated with tofacitinib was significantly lower than patients treated with placebo at week 44. |
| 2019-06-12 | Pfizer | Results Pfizer Announces Results from XELJANZ® XR (tofacitinib) ORAL Shift Study, The First Phase 3b/4 Study to Evaluate Methotrexate Withdrawal with a JAK Inhibitor pfizer.com ↗
The study demonstrated non-inferiority of MTX withdrawal with XELJANZ XR 11 mg QD compared to XELJANZ XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score (DAS28-4[ESR]) from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. |
| 2019-04-06 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Tofacitinib Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Tofacitinib Tablets (US RLD – Xeljanz® Tablets), 5 mg. |
| 2018-08-01 | Pfizer | Regulatory XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for Moderately to Severely Active Ulcerative Colitis pfizer.com ↗
The EC approval of XELJANZ provides an additional treatment option that can help improve the care of adults in Europe living with this debilitating inflammatory bowel disease. |
| 2018-06-28 | Pfizer | Regulatory XELJANZ® (tofacitinib citrate) Receives Marketing Authorisation in the European Union for Active Psoriatic Arthritis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. |
| 2018-05-30 | Pfizer | Regulatory Pfizer Announces U.S. FDA Approves XELJANZ® (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis pfizer.com ↗
With the FDA approval of XELJANZ, adults living with moderately to severely active UC now have an oral option that may help achieve and maintain steroid-free remission. |
| 2018-03-08 | Pfizer | Regulatory Pfizer Announces Favorable Outcome of FDA Advisory Committee Meeting on XELJANZ® (tofacitinib) for Moderately to Severely Active Ulcerative Colitis pfizer.com ↗
First, the Committee voted unanimously (15-0) in favor of the extension of the use of tofacitinib 10 mg BID from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by Week 8. |
| 2017-12-14 | Pfizer | Regulatory Pfizer Announces FDA Approval of XELJANZ® (tofacitinib) and XELJANZ® XR for the Treatment of Active Psoriatic Arthritis pfizer.com ↗
XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA. |
| 2017-12-12 | Pfizer | Regulatory U.S. Food And Drug Administration Extends Action Date For XELJANZ® (Tofacitinib) Supplemental New Drug Application In Ulcerative Colitis By Three Months pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ ® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). |
| 2017-08-03 | Pfizer | Regulatory FDA Advisory Committee Votes in Favor of XELJANZ® (tofacitinib citrate) for the Treatment of Active Psoriatic Arthritis pfizer.com ↗
Pfizer Inc. announced today that the United States Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis (PsA). |
| 2017-07-13 | Pfizer | Regulatory Pfizer Announces FDA Accepts Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis pfizer.com ↗
The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA. |
| 2017-06-16 | Pfizer | Results Pfizer Announces Results from XELJANZ® (tofacitinib citrate) ORAL Strategy Study Published in The Lancet and Presented at the EULAR Annual Congress pfizer.com ↗
“As expected, XELJANZ in combination with methotrexate provided similar ACR50 response rates to Humira plus methotrexate,” said Dr. Roy Fleischmann, study author and clinical professor |
| 2017-05-03 | Pfizer | Results Phase 3 OCTAVE Studies of Oral Tofacitinib in Ulcerative Colitis Results Published in The New England Journal of Medicine pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that detailed results from the Phase 3 Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) clinical program were published in The New England Journal of Medicine (NEJM). |
| 2017-05-03 | Pfizer | Regulatory Pfizer Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Active Psoriatic Arthritis pfizer.com ↗
Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). |
| 2017-03-27 | Pfizer | Regulatory XELJANZ® (tofacitinib citrate) Receives Marketing Authorisation in the European Union for the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ ® (tofacitinib citrate) 5 mg twice daily (BID) oral tablets |
| 2017-03-15 | Pfizer | Regulatory Pfizer Announces Approval By The China Food And Drug Administration Of XELJANZ®, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis pfizer.com ↗
XELJANZ ® is the first JAK inhibitor approved for RA patients. |
| 2017-02-16 | Pfizer | Results Pfizer Announces Top-Line Results from the Oral Strategy Trial of XELJANZ® (tofacitinib citrate) Compared to Humira® (adalimumab) pfizer.com ↗
XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX |
| 2017-01-27 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion in Europe for XELJANZ® (tofacitinib citrate) for the Treatment of Moderate to Severe Active Rheumatoid Arthritis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). |
| 2016-11-15 | Pfizer | Results Pfizer Announces Results from Phase 3 OPAL Clinical Development Program Investigating XELJANZ® (Tofacitinib Citrate) for Psoriatic Arthritis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that new results from the Phase 3 O ral P soriatic A rthritis Tria L (OPAL) studies, Broaden and Beyond, will be presented at the 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). |
| 2016-10-15 | Pfizer | Results Pfizer to Present New Data on XELJANZ® (Tofacitinib Citrate) for Ulcerative Colitis at UEG Week 2016 pfizer.com ↗
Tofacitinib has induction efficacy in moderately to severely active ulcerative colitis, regardless of prior TNF inhibitor therapy |
| 2016-07-28 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) in Ulcerative Colitis pfizer.com ↗
Top-line results from the OCTAVE Sustain study showed that the proportion of patients in remission at week 52, the primary efficacy endpoint, was significantly greater in both the tofacitinib 5 and 10 mg BID groups compared to placebo. |
| 2016-06-07 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Second Phase 3 Trial of Oral XELJANZ® (Tofacitinib Citrate) in Adults with Psoriatic Arthritis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today top-line results from Oral Psoriatic Arthritis triaL (OPAL) Beyond, the second Phase 3 study of XELJANZ ® (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA). |
| 2016-04-05 | Pfizer | Results Pfizer Announces Positive Top-Line Results from the First Phase 3 Trial of Investigational Tofacitinib in Adults with Psoriatic Arthritis pfizer.com ↗
OPAL Broaden met its primary efficacy endpoints demonstrating that both tofacitinib 5 mg BID and 10 mg BID were superior to treatment with placebo at 3 months as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score. |
| 2016-03-23 | Pfizer | Regulatory Pfizer Announces European Medicines Agency Accepted for Review Its Marketing Authorization Application for XELJANZ® (Tofacitinib Citrate) for the Treatment of Moderate to Severe Rheumatoid Arthritis pfizer.com ↗
The EMA will now initiate its review of the XELJANZ MAA. |
| 2016-03-18 | Pfizer | Results Pfizer Announces Oral Tofacitinib, an Investigational JAK Inhibitor, Meets Primary and Key Secondary Endpoints in Two Pivotal Phase 3 Ulcerative Colitis Trials pfizer.com ↗
Both OCTAVE Induction 1 and OCTAVE Induction 2 met their primary endpoint. |
| 2016-02-24 | Pfizer | Regulatory Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ ® XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). |
| 2015-10-14 | Pfizer | Regulatory Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ® (tofacitinib citrate) Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. |
| 2015-09-21 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Two Phase 3 Trials of Oral Tofacitinib in Adults with Moderate-to-Severe Ulcerative Colitis pfizer.com ↗
Both studies met their primary endpoints as measured by the proportion of patients receiving tofacitinib in remission at Week 8 compared to patients receiving placebo. |
| 2015-07-02 | Pfizer | Regulatory Pfizer Announces FDA Acceptance for Review of New Drug Application for A Once-Daily Formulation of XELJANZ® (tofacitinib citrate) Modified Release Tablets pfizer.com ↗ |
| 2015-06-10 | Pfizer | Results Pfizer Builds Upon Robust Body Of Knowledge For XELJANZ® (tofacitinib citrate) With Clinical Trial And Real-World Use Data At The European League Against Rheumatism Annual Congress (EULAR 2015) pfizer.com ↗
Notably, new results from the XELJANZ 11 mg once daily clinical pharmacology program will be presented during the Congress, demonstrating equivalence in key pharmacokinetic parameters to XELJANZ 5 mg twice daily. |
| 2015-03-20 | Pfizer | Results Pfizer Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials pfizer.com ↗
tofacitinib 10 mg and 5 mg tablets twice daily met the co-primary efficacy endpoints of superiority over placebo at 16 weeks |
| 2015-02-04 | Pfizer | Regulatory Pfizer Announces FDA Acceptance For Review Of Supplemental New Drug Application For Oral XELJANZ® (tofacitinib citrate) For Adult Patients With Moderate To Severe Chronic Plaque Psoriasis pfizer.com ↗ |
All press releases naming this drug 55 releases
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 258 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tofacitinib | “One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2,...” PMID 22894574 ↗ Aug 2012195“A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid...” PMID 22006202 ↗ Oct 2011 “This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when...” NCT02084875 ↗ “The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab....” NCT04114461 ↗ “We randomly assigned 958 patients to receive 5 mg or 10 mg of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks;...” PMID 24941177 ↗ Jun 2014 “Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a...” PMID 23294500 ↗ Jan 2013 “Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid...” NCT07406932 ↗ “Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite...” NCT04692493 ↗ “Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.” PMID 22873530 ↗ Aug 2012 “BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon.” NCT06275464 ↗ “Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study.” PMID 23348607 ↗ Mar 2013 |
| Known as | CKD-374 | “CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition” NCT03858725 ↗ |
| Known as | CP-6890,550 | “(CP-6890,550) Tofacitinib” NCT01710046 ↗ |
| Known as | CP-690 | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | CP-690 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | CP-690,55 | “Tasocitinib (CP-690,55) plus Ketoconazole” NCT01202240 ↗ |
| Known as | CP-690,550 | “One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2,...” PMID 22894574 ↗ Aug 201276“A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN...” NCT03486457 ↗ “Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an...” PMID 21952978 ↗ Mar 2012 “This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when...” NCT02487433 ↗ “This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when...” NCT02084875 ↗ “A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And...” NCT01882439 ↗ “This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30...” NCT01499004 ↗ “Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.” PMID 22873530 ↗ Aug 2012 “Tofacitinib (CP-690,550) is a novel Janus kinase inhibitor in development as an oral formulation for the treatment of several inflammatory diseases including psoriasis.” PMID 23387374 ↗ Jul 2013 “This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (CP-690,550) in the subjects with moderate to severe dry eye disease.” NCT01226680 ↗ “A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients” NCT00556257 ↗ |
| Known as | CP-690,550 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | CP-690,550-10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | Cp-690550 citrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | PFE-PKIS 25 | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | tasocitinib | “a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions.” NCT01184001 ↗ |
| Known as | tasocitinib citrate | “Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet” NCT01184092 ↗ |
| Known as | Tasocitinib monocitrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | TOF | “This post hoc analysis assessed the effect of baseline C-reactive protein (CRP) on the efficacy and safety of tofacitinib (TOF) use in ankylosing spondylitis (AS), as well as...” PMID 38825359 ↗ Aug 20241“OBJECTIVE: To evaluate the effect of tofacitinib (TOF) on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA).” PMID 35232809 ↗ Mar 2022 |
| Known as | TOFA | “either Tofacitinib (TOFA) or etanercept (ETA).” NCT04485325 ↗ |
| Known as | TOFACITINIB (CONTROLLED RELEASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | TOFACITINIB (CP-690550) | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | Tofacitinib Citrate | “In 2014, the first reported case using a JAK1/3 inhibitor, tofacitinib citrate, for the treatment of AU was described in a patient with concomitant plaque psoriasis who...” NCT06278402 ↗3“using the pan-JAK inhibitor, tofacitinib citrate, for AA with >50% scalp hair loss, alopecia totalis (AT), and alopecia universalis (AU).” PMID 27699252 ↗ Sep 2016 “Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months.” NCT06157905 ↗ “Drug: Tofacitinib Citrate” NCT05487963 ↗ |
| Known as | Tofacitinib monocitrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | Xeljanz | “This study aimed to evaluate the bioequivalence of the pharmacokinetics (PK) between tofacitinib aspartate 7.13 mg (test formulation) and tofacitinib citrate 8.08 mg (reference...” PMID 33062629 ↗ Sep 20209“A novel treatment for these refractory cases is tofacitinib (Xeljanz®), a synthetic small molecule inhibitor of JAK kinases” NCT05313620 ↗ “Single Oral Administration of Xeljanz 5 mg Tablet” NCT04468425 ↗ “Tofacitinib (Xeljanz®; 5 mg twice daily, p.o.)” NCT04485325 ↗ “Tofacitinib 10 MG [Xeljanz]” NCT04925973 ↗ “Tofacitinib 10 MG [Xeljanz]” NCT03681275 ↗ “Tofacitinib 5 MG [Xeljanz]” NCT03755466 ↗ “Tofacitinib 5 MG [Xeljanz]” NCT04141904 ↗ “XELJANZ (tofacitinib)” NCT05104723 ↗ |
| Known as | Xeljanz xr | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | XELJANZ(R) | “XELJANZ(R) is the citrate salt of tofacitinib.” NCT04496960 ↗ |
| Action | Inhibit | “Janus kinase inhibitor CP-690,550” PMID 19660021 ↗ Aug 2009 |
| Modality | Small molecule | “Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC).” PMID 32816215 ↗ Aug 2020 |
| Route | Oral | “Oral tablets administered at a dose of 5 mg BID for 6 weeks” NCT00147498 ↗ |
| Target | JAK3 | “JAK3 inhibitor” NCT00556257 ↗ |